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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Synkem SAS - Close Out Letter 2/2/10

 

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 CENTER FOR DRUG EVALUATION AND RESEARCH
Division of Manufacturing and Product Quality
International Compliance Team
10903 New Hampshire Avenue
Building #51, Room 4225
Silver Spring, MD 20993
TELEPHONE: (301) 796-3334
FAX: (301) 847-8742466

2 February 2010

Mr. Henri Mandrillon
President
Synkem SAS
47 Rue De Longvie
B.P.50
21301, Chenove Cedex
France

RE: Inspection of firm FEI 3002808295

Dear Mr. Mandrillon:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter WL: 320-09-04 dated May 6, 2009. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have any questions regarding this letter, you may contact me at the above address or number.

Sincerely,

/s/


Maan Abduldayem
Compliance Officer
International Compliance Team